Improving Post-Transplant Communication of New Donor Information

1. Improving Post-Transplant Communication of New Donor Information Ad Hoc Disease Transmission Advisory Committee Spring 2016

2. What problem will the proposal solve? • Communication delays or failures about new donor information learned post-transplant have led to transplant recipient morbidity and mortality • Policy requirement: must report PDDTE to patient safety contact and OPTN Improving Patient Safety Portal (IPS) • General policy language allows reporting to vary • Over and under reporting exist • Process doesn’t always function as intended

3. What is the goal of the proposal? • Provide more specific reporting guidelines • What types of results • Who needs to receive report • When do they need to receive it • More standardized and efficient communication • Devote resources and attention to most critical results

4. How does the proposal address the problem statement?

5. OPOs must report the following positiveresults: 1Candida from sterile sites needs to be reported within 24 hours

6. OPOs must report the following positiveresults: *Mycobacterial and fungal (with the exception of Candida species) positive results must be reported to the transplant program’s recipient of any organ

7. How does the proposal address the problem statement?

8. Supporting Evidence • Failure Modes and Effects Analysis (FMEA) conducted on Post Transplant Results Communication • 8 process steps: 28 potential failure modes • 17 recommendations on 16 highest failure modes • Proposal addresses six of the recommendations

9. Supporting Evidence: Communication Gaps Impact Infectious Disease Transmissions What Contributed? • Transplant center delayed contacting the OPO with a suspected donor derived infection • Failure of labs to relay donor results to the OPO and/or transplant center • OPO delay in contacting DTAC or transplant centers • Clerical errors • Test results communicated by OPO to transplant centers was incomplete What happened? • 18 of 56 (32%) infectious events (IE) had communication gap or delay • 12 of 18 (67%) IE had adverse event • 20 out of 29 recipients experienced adverse event • 6 deaths R Miller et al, “Communication Gaps Associated with Donor-Derived Infections,” American Journal of Transplantation 15 (2015): 259-264.

10. Supporting Evidence:Percent of Deceased Donors Recovered 2013-2014 with Case Reported and Proven/Probable Case through 8/21/2015 by Region of Recovery

11. How will members implement this proposal? • OPOs and transplant hospitals need to familiarize staff responsible for PDDTE reporting with the new policy • OPOs need to develop a reporting protocol that includes: • Obtaining all results for any deceased donor testing conducted • Uploading all deceased donor testing results to DonorNet • Sharing relevant deceased donor test results with tissue banks • Reporting specified positive test results to the transplant hospital patient safety contact (as soon as possible but no later than 24 hours of receipt) • Reporting specified positive test results to the OPTN (as soon as possible but no later than 24 hours of receipt)

12. How will members implement this proposal? • Transplant hospitals need to: • Report to the host OPO all toxoplasmosis results (including negative results) conducted on deceased donor samples • Continue to report suspected cases of donor-derived transmissions • Living donor recovery hospitals need to: • Report all risk of potential transmission of disease or malignancy as soon as possible but no more than seven days after receipt of the new information • Continue to report suspected cases of donor-derived transmissions

13. How does this proposal support the OPTN Strategic Plan? • Promote living donor and transplant recipient safety: This proposal will : • 1. Clarify expectations regarding how OPOs report new donor information learned post-transplant • 2. Triage direction on how this information is shared to reduce: • Burdens of both sharing and receiving • Perceived desensitization within the community due to the "noise" currently flooding the current reporting systemand allow more focus on critical results

14. Summary • Many results will not require urgent communication • Routine urine cultures (non-kidney recipient center) • Routine sputum cultures (non-lung recipient center) • Focus on recipient disease rather than donor cultures in reporting to the OPTN • Exception for pathogens where CDC investigation may be able to assist transplant centers • Sharing toxoplasmosis results with all recipient centers • Difficulties with communicating and performing donortesting when done at heart center • Recent recognition that these results are relevant to non-heart recipients

15. Feedback needed • What are both the OPO and transplant hospital experiences in this region with toxoplasmosis testing? • DTAC is considering requiring all OPOs to conduct toxoplasmosis testing to: • Overcome logistical challenges for transplant hospitals to complete the testing • Assure that disease in non-cardiac recipients is not missed • Seeking VCA specific feedback

16. Questions? Daniel Kaul MD Committee Chair kauld@med.umich.edu Susan Tlusty Committee Liaison susan.tlusty@unos.org

17. Extra Slides

18. Supporting Evidence • FMEA conducted on Post Transplant Results Communication

19. Supporting Evidence • FMEA conducted on Post Transplant Results Communication

20. Supporting Evidence:Historical Trends of PDDTE Reporting to the OPTN